SAN DIEGO - Biora Therapeutics, Inc. (NASDAQ:BIOR), a biotech firm focused on innovative therapeutic delivery, has announced the completion of the single-ascending dose (SAD) cohorts in its phase 1 clinical trial of BT-600, a novel drug-device combination aimed at treating moderate to severe ulcerative colitis. The company is preparing to commence the multiple-ascending dose (MAD) cohorts in March, with expectations to share SAD data during its corporate update the same month.
BT-600 employs Biora's NaviCap™ device to deliver a liquid formulation of the drug tofacitinib directly to the colon, potentially enhancing efficacy and reducing systemic side effects. The phase 1 study, conducted in the United States, is designed to assess the safety, pharmacokinetics, and pharmacodynamics of the treatment.
Dr. Ariella Kelman, Chief Medical Officer of Biora Therapeutics, expressed satisfaction with the study's execution and its progress. She highlighted the potential of BT-600 to deliver better outcomes for patients due to increased colonic tissue exposure and reduced systemic-exposure-related adverse events.
The phase 1 study consists of two parts: the completed SAD cohort with 24 participants and the upcoming MAD cohort, also with 24 participants, which will receive varying doses of tofacitinib or placebo. Final study data, including results from both cohorts, is anticipated in the second quarter.
Biora's NaviCap targeted oral delivery platform is part of the company's broader initiative to improve patient outcomes through direct therapeutic delivery to disease sites. The platform's GItrac™ autolocation technology enables precise drug release in the gastrointestinal tract, a significant advancement for the treatment of IBD.
Ulcerative colitis is a chronic inflammatory bowel disease affecting approximately 1.5 million people in the United States. Current treatments do not achieve clinical remission in a significant number of patients, necessitating continued innovation in therapeutic delivery.
The information in this article is based on a press release statement from Biora Therapeutics.
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